FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: QIH ×
313 results
49–72 of 313
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 29, 2026
Surgical Reality Viewer
K252091 · QIH
Medicalvr B.V.
Radiology · 210d
Cleared Jan 29, 2026
Neurophet AQUA AD Plus
K252496 · QIH
Neurophet., Inc.
Radiology · 174d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jan 22, 2026
AV Vascular
K253735 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jan 16, 2026
Imagine® Enterprise Suite
K252634 · QIH
Softlink International Private Limited
Radiology · 149d
Cleared Dec 30, 2025
TruSPECT Processing Station
K253532 · QIH
Spectrum Dynamics Medical, Ltd.
Radiology · 47d
Cleared Dec 22, 2025
PeekMed web
K252856 · QIH
Peek Health, S.A.
Radiology · 104d
Cleared Dec 19, 2025
AI-CVD
K252029 · QIH
HeartLung Corporation
Radiology · 172d
Cleared Dec 19, 2025
Alzevita
K252670 · QIH
TOPIA MEDTECH LIMITED
Radiology · 116d
Cleared Dec 18, 2025
MediAI-BA
K250914 · QIH
Crescom Co., Ltd.
Radiology · 266d
Cleared Dec 18, 2025
PVAD IQ Software
K252235 · QIH
Ultrasight , Ltd.
Radiology · 154d
Cleared Dec 17, 2025
Neosoma Brain Mets
K252922 · QIH
Neosoma, Inc.
Radiology · 93d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 05, 2025
Overjet CBCT Assist
K251514 · QIH
Overjet, Inc.
Radiology · 203d
Cleared Dec 02, 2025
Acorn 3D Software (AC-SEG-4009)
K252103 · QIH
Mighty Oak Medical
Radiology · 152d
Cleared Nov 14, 2025
AutoDensity
K251078 · QIH
Eos Imaging
Radiology · 220d
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d
Cleared Nov 03, 2025
3mensio Workstation
K250330 · QIH
Pie Medical Imaging BV
Radiology · 271d
Cleared Oct 30, 2025
AiORTA - Plan
K250337 · QIH
ViTAA Medical Solutions, Inc.
Radiology · 266d
Cleared Oct 27, 2025
cvi42 Coronary Plaque Software Application
K251027 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 208d
Cleared Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059 · QIH
Siemens Healthineers AG
Radiology · 203d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 20, 2025
brAIn™ Shoulder Positioning
K252665 · QIH
Avatar Medical
Radiology · 56d